Video gaming for cognitive functioning of people with schizophrenia: a single-blind, individually randomised three-arm parallel-group controlled trial in Hong Kong (GAME-S)

In this single-blind, individually randomised three-arm parallel-group controlled trial in Hong Kong, we recruited persons in outpatient settings, aged 18–60 years and diagnosed with schizophrenia. Using a computer-generated random number list (blocks size 6), participants were randomly assigned (1:1:1) into a computerised brain training group (CogniFit), an entertainment gaming group (SIMS 4) in addition to usual treatment (TAU), or a TAU only group. Over a 12-week period, gaming (5 times/week, 60 minutes each time) was supported by trained facilitators. The data collectors were not blinded, but the statistician was blinded to treatment allocation. Verbal working memory (Letter-Number-Span-Test, LNST) was the primary outcome, measured at 3 and 6 months and analysed using the intention-to-treat principle. Safety was monitored through the course of the intervention and assessed in all randomly assigned patients for any adverse events. The trial was registered at ClinicalTrials.gov (NCT03133143) and is complete. Findings: From 16 May 2019 to 11 November 2020, 1432 patients were assessed for eligibility. Of these, 144 were willing to join the study (10·1%), and 131 (mean age 45·1 years [SD 9·5]) were randomly allocated to either the CogniFit (n=45), SIMS 4 (n=43) or TAU (n=43) group. The final intervention took place on 25 July 2021. The final 6-month outcome assessment was completed on 30 October 2021.本研究为一项在香港开展的单盲、个体随机三臂平行对照试验，招募了门诊就诊的18-60岁确诊精神分裂症患者。采用计算机生成的随机数列表（区组长度为6），以1:1:1的比例将受试者随机分配至三组：计算机化脑训练组（CogniFit）、常规治疗（TAU）联合娱乐游戏组（SIMS 4），以及仅常规治疗组。在为期12周的干预期间，游戏训练（每周5次，每次60分钟）由经过培训的督导人员提供支持。数据收集人员未设盲，但统计师对治疗分配设盲。主要结局指标为言语工作记忆，通过字母-数字广度测验（Letter-Number-Span-Test, LNST）进行评估，分别于干预后3个月和6个月开展测评，并采用意向性治疗原则开展数据分析。研究全程监测安全性，对所有随机分配的患者均评估不良事件发生情况。本试验已在ClinicalTrials.gov（注册号：NCT03133143）注册，且已完成。 研究结果：2019年5月16日至2020年11月11日期间，共对1432例患者进行入组资格筛查。其中144例（10.1%）自愿参与本研究，最终131例受试者（平均年龄45.1岁，标准差9.5）被随机分配至CogniFit组（n=45）、SIMS 4组（n=43）或仅TAU组（n=43）。最终干预于2021年7月25日完成，末次6个月结局评估于2021年10月30日完成。